DeZwarteRidder schreef op 10 september 2020 16:22:
zo zal het ook met Kiadis gaan:
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Satsuma Pharmaceuticals Inc (NASDAQ: STSA) is falling like a brick thrown from the Empire State Building this morning, and for good reason. The company released topline data from a Phase 3 study that missed the mark. Here’s what’s happening:
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STSA Stock Falls Hard On Clinical Data
In a press release issued this morning, Satsuma Pharmaceuticals provided topline results from its Phase 3 Emerge efficacy trial. The trial assessed STS101 powder as a potential treatment for migraine headaches.
The trial failed to meet its co-primary efficacy endpoints.
In the release, STSA said that the treatment did show improvement over placebo in both pre-specified co-primary endpoints, but that the differences were not statistically significant. The measures of efficacy included freedom from pain and freedom from most bothersome symptom at two hours post-administration.
The company said that while the co-primary endpoints were missed, the treatment did show significant effects in terms of freedom from pain and most bothersome symptom by three hours post-dose and at later time points.
In a statement, John Kollins, President and CEO at STSA, had the following to offer:
We are surprised and disappointed that STS101 did not achieve statistical significance on the co-primary endpoints in our EMERGE trial. On behalf of everyone at Satsuma, I’d like to thank the many people with migraine who participated in EMERGE as well as the staff at the trial sites for their dedication and diligence in completing the trial, despite the challenges posed by the ongoing COVID-19 pandemic.